loperamide hydrochloride

Generic: loperamide hydrochloride

Labeler: aurohealth llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name loperamide hydrochloride
Generic Name loperamide hydrochloride
Labeler aurohealth llc
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

loperamide hydrochloride 2 mg/1

Manufacturer
Aurohealth LLC

Identifiers & Regulatory

Product NDC 58602-727
Product ID 58602-727_f9a53a23-a8ea-4521-8f0b-1bc2a658ff68
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA220372
Listing Expiration 2027-12-31
Marketing Start 2025-12-29

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 58602727
Hyphenated Format 58602-727

Supplemental Identifiers

RxCUI
978006
UNII
77TI35393C

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name loperamide hydrochloride (source: ndc)
Generic Name loperamide hydrochloride (source: ndc)
Application Number ANDA220372 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (58602-727-74) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 2 BLISTER PACK in 1 CARTON (58602-727-75) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 4 BLISTER PACK in 1 CARTON (58602-727-76) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
  • 3 BLISTER PACK in 1 CARTON (58602-727-80) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (4)

58602-727-74 1 BLISTER PACK in 1 CARTON (58602-727-74) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 58602-727-75 2 BLISTER PACK in 1 CARTON (58602-727-75) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 58602-727-76 4 BLISTER PACK in 1 CARTON (58602-727-76) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 58602-727-80 3 BLISTER PACK in 1 CARTON (58602-727-80) / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (1)

loperamide hydrochloride (2 mg/1)

Linked Drug Pages (1)

LOPERAMIDE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "f9a53a23-a8ea-4521-8f0b-1bc2a658ff68", "openfda": {"unii": ["77TI35393C"], "rxcui": ["978006"], "spl_set_id": ["f9a53a23-a8ea-4521-8f0b-1bc2a658ff68"], "manufacturer_name": ["Aurohealth LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (58602-727-74)  / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "58602-727-74", "marketing_start_date": "20251229"}, {"sample": false, "description": "2 BLISTER PACK in 1 CARTON (58602-727-75)  / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "58602-727-75", "marketing_start_date": "20251229"}, {"sample": false, "description": "4 BLISTER PACK in 1 CARTON (58602-727-76)  / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "58602-727-76", "marketing_start_date": "20251229"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (58602-727-80)  / 6 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "58602-727-80", "marketing_start_date": "20251229"}], "brand_name": "LOPERAMIDE HYDROCHLORIDE", "product_id": "58602-727_f9a53a23-a8ea-4521-8f0b-1bc2a658ff68", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "58602-727", "generic_name": "LOPERAMIDE HYDROCHLORIDE", "labeler_name": "Aurohealth LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "LOPERAMIDE HYDROCHLORIDE", "active_ingredients": [{"name": "LOPERAMIDE HYDROCHLORIDE", "strength": "2 mg/1"}], "application_number": "ANDA220372", "marketing_category": "ANDA", "marketing_start_date": "20251229", "listing_expiration_date": "20271231"}